Imagine a clinical trial that works like a smart filter, quickly swapping out ineffective medicines for better ones without starting from scratch. This project builds that system to find the best antibiotic doses for newborns in Africa. It helps doctors stop guessing and start using treatments that actually work against resistant bacteria.
High neonatal mortality in sub-Saharan Africa is driven by antimicrobial resistance and a lack of precise antibiotic dosing. Current clinical trials are too slow to adapt to these rapidly changing bacterial trends.
A multi-country adaptive trial platform including a master protocol, governance charter, and real-time AMR surveillance dashboards.
If you are a generic antibiotic manufacturer dealing with imprecise dosing guidelines for infants — this project developed pharmacokinetic studies that optimize dosing for key antimicrobials. This allows for more precise product labeling and improved patient outcomes in emerging markets.
If you are a CTMS provider dealing with the difficulty of managing multi-country adaptive trials — this project developed a master protocol and governance charter for a scalable trial platform. This provides a blueprint for digitizing complex, real-time trial adjustments across 9 countries.
If you are a diagnostic company dealing with a lack of real-time AMR data — this project developed surveillance dashboards to monitor microbiological trends across 7 neonatal units. This data helps target the deployment of new diagnostic tools to high-need areas.
Based on available project data, the EU contribution is EUR 7,168,901, but there is no specific commercial price for the resulting platform or protocols.
Yes, the project is designing a scalable and adaptable trial platform that can be extended to include older children with infections.
Based on available project data, specific IP or licensing agreements are not mentioned; the project focuses on building a research network and architecture.
It integrates via a multi-country clinical research platform and real-time surveillance dashboards across 7 neonatal units in 5 countries.
The project runs from 2023-07-01 to 2028-06-30, with initial surveillance and PK protocols already developed by December 2024.
The consortium is heavily weighted toward academic and research institutions, consisting of 6 universities and 5 research organizations across 9 countries. There is a notable absence of large-scale industrial partners (0%), with only 1 SME involved. This suggests the output is currently high-level scientific evidence and operational protocols rather than a commercial product.
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